Results of April EU/India Audit

November 8, 2018
The EU audit report of the April visit of FVO has been published just now. The key finding of the report relevant for aquaculture is the following:
  • It is concluded that the already EU-approved residue monitoring plans for aquaculture, eggs and honey are elaborated in a timely fashion and are implemented as planned and, with regard to aquaculture, is supported by extensive additional pre-harvest and pre-export testing programmes which focus on a limited range of substances. Notwithstanding these positive aspects, the effectiveness of the plans is nevertheless weakened by the fact that many pharmacologically active substances available on the market are not currently included in the scope of testing for the three commodities. Furthermore, the information on laboratory testing and capability provided in the plans submitted to the Commission did not reflect what was happening in reality.
More detailedly the report concludes the following:
  • Follow-up of RASFF alerts follows the principles expected in the EU framework. The ability to definitively trace the origin of violative residues is compromised by widespread over-the-counter availability of veterinary medicinal products with no requirement to keep purchase records. Furthermore the lack of legal tools to sanction producers which have tested positive reduces the effectiveness of the residues control system.
The report explains that as of the Commission Decision 2010/381/EU2, as last amended, requires to test consignments of certain foodstuffs Indian origin arriving at EU borders for chloramphenicol, tetracycline, oxytetracycline, chlortetracycline and metabolites of nitrofurans (AOZ, SEM, AHD and AMOZ).
The key recommendation provided in the report is that India has to expand the number of substances that have to be tested has to be increased in order to better reflect the products that are available to farmers in India. The exact text of the recommendation is the following
  • Ensure that the scope of testing carried out under the residue monitoring plan includes all relevant substances in line with the range of veterinary medicinal products on the market, to ensure that the guarantees provided by the plans for aquaculture, eggs and honey under Article 29 of Council Directive 96/23/EC are effective. Recommendation based on conclusion: 27 and Associated findings: 4, 6, 15, 21, 24, 26, 143, 148
The response of the Indian authorities has been the following.
  • The scope of testing for relevant substances in line with the range of veterinary medicinal products on the market shall be included in the NRCP/ RMP plans for aquaculture, eggs and honey as per Article 29 of Council Directive 96/23/EC. Relevant methods shall also be validated to implement effectively to cover the veterinary medicinal products available in the market.
    • 1. Deadline of completion: December 2018 for NRCP for aquaculture products
    • In view of the above, the recommendation may be closed.
There is no mention in the report about which additional substances will be added to the list but it’s clear that the list will be expanded. SIPA informed us that also from the official summary of the PAFF meeting in Brussels it seems that the EU is considering to expand residues which are tested for at the EU borders ( in addition to the already ongoing testing for chloramphenicol, tetracycline, oxytetracycline, chlortetracycline and metabolites of nitrofurans, focus should also be put on the testing of macrolides, aminoglycosides, beta-lactams including cephalosporins, lincosamides, diaminopyrimidines and doxycycline). This is in line with the recommendation to the Indian authorities and is therefore likely to happen.
Unfortunately, there is no mention in the report or the summary of the PAFF meeting about whether the testing ratio will change or whether the policy of delisting companies after a rejection will change. We will try to follow up on this in Delhi and Brussels and keep you informed if we hear more about this.

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